RISPERDAL CONSTA 50 mg POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INTRAMUSCULAR INJECTION

Introduction

Package Leaflet: Information for the User

Risperdal Consta 50 mg powder and solvent for prolonged-release suspension for injection

risperidone

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you., as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Risperdal Consta is and what it is used for
2. What you need to know before you use Risperdal Consta
3. How to use Risperdal Consta
4. Possible side effects
5. Storing Risperdal Consta
6. Contents of the pack and other information

1. What Risperdal Consta is and what it is used for

Risperdal Consta belongs to a group of medicines called “antipsychotics”.

Risperdal Consta is used in the maintenance treatment of schizophrenia, which is characterized by seeing, hearing, or feeling things that are not there, believing in something that is not true, or unusually feeling suspicious or confused.

Risperdal Consta is intended for patients who are currently being treated with oral antipsychotics (e.g., tablets, capsules).

Risperdal Consta may help reduce the symptoms of your illness and prevent them from coming back.

2. What you need to know before you use Risperdal Consta

Do not use Risperdal Consta

• If you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• If you have never taken Risperdal in any of its forms, you should start with oral Risperdal before starting Risperdal Consta.

Talk to your doctor or pharmacist before using Risperdal Consta if:

• You have a heart problem. For example, an irregular heartbeat, or if you are prone to having low blood pressure or if you are taking medicines for blood pressure. Risperdal Consta may lower your blood pressure. Your dose may need to be adjusted.
• You know you have any factors that make you prone to having a stroke, such as high blood pressure, cardiovascular disorders, or disorders of the cerebral circulation.
• You have ever had involuntary movements of the tongue, mouth, and face.
• You have ever had symptoms that include fever, muscle stiffness, sweating, or a decrease in the level of consciousness (also known as Neuroleptic Malignant Syndrome).
• You have Parkinson's disease or dementia.
• If you have had low white blood cell counts in the past (which may or may not have been caused by other medicines).
• You are diabetic.
• You have epilepsy.
• You are male and have ever had a prolonged or painful erection.
• You have difficulty controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of a hormone called prolactin in your blood or if you have a tumor that is possibly dependent on prolactin.
• You or a family member have blood clotting problems, as medicines like this have been associated with the formation of blood clots.

If you are unsure about any of the above, talk to your doctor or pharmacist before using Risperdal or Risperdal Consta.

Because it has been very rarely observed in patients treated with Risperdal Consta that there is a dangerously low number of a type of white blood cell necessary to fight infections in the blood, your doctor may check your white blood cell count.

Rarely, allergic reactions occur after receiving Risperdal Consta injections, even if you have previously tolerated oral risperidone. Seek medical attention immediately if you experience hives, swelling of the throat, itching, or breathing problems, as these may be symptoms of a severe allergic reaction.

Risperdal Consta may cause you to gain weight. Significant weight gain can affect your health unfavorably. Your doctor will regularly monitor your weight.

Because diabetes mellitus or worsening of pre-existing diabetes mellitus has been seen in patients taking Risperdal, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored regularly.

Risperdal Consta often increases the levels of a hormone called “prolactin”. This can cause side effects such as menstrual disorders or fertility problems in women or breast swelling in men (see Possible side effects). If these side effects occur, it is recommended to evaluate prolactin levels in the blood.

During eye surgery for cataracts, the pupil (the black circle in the middle of the eye) may not increase in size as needed. Additionally, the iris (the colored part of the eye) may become flaccid during surgery, which can cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are using this medicine.

Elderly patients with dementia

Risperdal Consta is not used in elderly patients with dementia.

If you or your caregiver notice a sudden change in your mental state or the sudden appearance of weakness or numbness in the face, arms, or legs, especially on one side, or confused speech, even if only for a short time, seek medical attention immediately. It may be a sign of a stroke.

Patients with kidney or liver problems

Although oral risperidone has been studied, Risperdal Consta has not been studied in patients with kidney or liver problems. Risperdal Consta should be administered with caution in this group of patients.

Using Risperdal Consta with other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicines.

It is especially important that you talk to your doctor or pharmacist if you are taking any of the following

• Medicines that act on the brain used to calm down (benzodiazepines) or some pain medicines (opioids), allergy medicines (some antihistamines), as risperidone may increase the sedative effect of all these.
• Medicines that can change the electrical activity of your heart, such as those used for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants, or other medicines for mental problems.
• Medicines that can cause a decrease in heart rate.
• Medicines that can cause a decrease in potassium levels in the blood (such as certain diuretics).
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).
• Medicines for high blood pressure. Risperdal Consta may lower blood pressure.
• Diuretics used for heart problems or to treat swelling of some parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperdal Consta, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone

• Rifampicin (a medicine used to treat some infections).
• Carbamazepine, phenytoin (medicines used to treat epilepsy).
• Phenobarbital.

If you start or stop taking these medicines, you may need a different dose of risperidone.

The following medicines may increase the effect of risperidone

• Quinidine (a medicine used to treat certain types of heart problems).
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants.
• Medicines known as beta-blockers (used to treat high blood pressure).
• Phenothiazines (such as medicines used to treat psychosis or to calm down).
• Cimetidine, ranitidine (medicines used to treat stomach acid).
• Itraconazole and ketoconazole (medicines used to treat fungal infections).
• Some medicines used to treat HIV/AIDS, such as ritonavir.
• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.

If you start or stop taking these medicines, you may need a different dose of risperidone.

If you are unsure about any of the above, talk to your doctor or pharmacist before using Risperdal Consta.

Using Risperdal Consta with food, drinks, and alcohol

You should avoid consuming alcohol while using Risperdal Consta.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide if you can use it.
• The following symptoms may occur in newborn babies of mothers who have been treated with Risperdal Consta in the last trimester of pregnancy (last three months of pregnancy): trembling, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.
• Risperdal Consta may increase the levels of a hormone called “prolactin” that could affect your fertility (see Possible side effects).

Driving and using machines

Dizziness, fatigue, and vision problems have been observed during treatment with Risperdal Consta. Do not drive or use tools or machinery without consulting your doctor first.

Risperdal Constacontains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially “sodium-free”.

3. How to use Risperdal Consta

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Risperdal Consta is administered by intramuscular injection into the arm or buttock every two weeks, by a healthcare professional. Injections should be alternated between the left and right sides and should not be administered intravenously.

The recommended dose is as follows:

Adults

Initial dose

If your daily dose of oral risperidone (e.g., tablets) was 4 milligrams or less during the two weeks prior, your starting dose should be 25 milligrams of Risperdal Consta.

If your daily dose of oral risperidone (e.g., tablets) was more than 4 milligrams during the two weeks prior, you may be given a dose of 37.5 milligrams of Risperdal Consta as the starting dose.

If you are currently being treated with another oral antipsychotic that is not risperidone, your starting dose of Risperdal Consta will depend on your current treatment. Your doctor will choose Risperdal Consta 25 mg or 37.5 mg.

Your doctor will decide if this dose of Risperdal Consta is suitable for you.

Maintenance dose

• The usual dose is an injection of 25 milligrams every two weeks.
• A higher dose of 37.5 or 50 mg may be necessary. Your doctor will decide which dose of Risperdal Consta is most suitable for you.
• Your doctor may prescribe oral Risperdal for the first three weeks after the first injection.

If you use more Risperdal Consta than you should

• People who have used more Risperdal Consta than they should have experienced the following symptoms: drowsiness, fatigue, abnormal body movements, problems standing and walking, feeling dizzy due to low blood pressure, and abnormal heartbeats. There have been reports of anomalies in the electrical conduction of the heart and seizures.
• Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount taken.

It is recommended to take the packaging and the package leaflet of the medicine to the healthcare professional.

If you stop using Risperdal Consta

The effects of this medicine will be lost. You should not stop using this medicine unless your doctor tells you to, as you may experience the symptoms again. Make sure to receive your injections every two weeks. If you cannot attend your appointments, contact your doctor immediately to schedule another appointment when you can.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Use in children and adolescents

Children and adolescents under 18 years of age should not receive Risperdal Consta.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Report immediately to your doctor if you experience any of the following rare adverse effects (may affect up to 1 in 100 patients):

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or have difficulty speaking even for a short period. These may be signs of a stroke.
• You experience tardive dyskinesia (involuntary spasms or twitching movements that cannot be controlled in the face, tongue, or other parts of the body). Report to your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, and face. It may be necessary to withdraw Risperdal Consta.

Report immediately to your doctor if you experience any of the following rare adverse effects (may affect up to 1 in 1,000 patients):

• You experience blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can circulate through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You experience fever, muscle stiffness, sweating, or a decrease in the level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). You may need immediate medical treatment.
• You are a man and experience a prolonged or painful erection. This is known as priapism. You may need immediate medical treatment.
• You experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or a drop in blood pressure. Even if you have previously tolerated oral risperidone, allergic reactions can rarely occur after receiving Risperdal Consta injections.

The following adverse effects may also occur:

Very Common Adverse Effects (may affect more than 1 in 10 people)

• Common cold symptoms.
• Difficulty staying or falling asleep.
• Depression, anxiety.
• Parkinsonism: This disease may include slow or altered movement, feeling of stiffness or tightness of the muscles (making jerky movements), and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include walking slowly, dragging feet, tremors at rest, increased saliva and/or drooling, and loss of facial expressiveness.
• Headache.

Common Adverse Effects (may affect up to 1 in 10 people)

• Pneumonia, chest infection (bronchitis), sinusitis.
• Urinary tract infection, feeling like you have the flu, anemia.
• Increased levels of a hormone called "prolactin" that is detected in blood tests (which may or may not cause symptoms). Symptoms of increased prolactin appear rarely and in men may include breast swelling, difficulty having or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, they may include breast tenderness, milk secretion from the breasts, loss of menstrual periods, or other problems with the cycle or fertility issues.
• Increased blood sugar, weight gain, increased appetite, weight loss, decreased appetite.
• Sleep disorder, irritability, decreased sexual desire, restlessness, feeling drowsy or less attentive.
• Dystonia: This is a disease that involves slow or continuous involuntary contraction of the muscles. Although any part of the body can be affected (and can cause abnormal postures), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
• Dizziness.
• Dyskinesia: This disease involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms.
• Tremors (shakiness).
• Blurred vision.
• Fast heart rate.
• Decreased blood pressure, chest pain, increased blood pressure.
• Shortness of breath, sore throat, cough, nasal congestion.
• Abdominal pain, abdominal discomfort, vomiting, nausea, stomach or intestinal infection, constipation, diarrhea, indigestion, dry mouth, toothache.
• Skin rash.
• Muscle spasms, bone or muscle pain, back pain, joint pain.
• Urinary incontinence.
• Erectile dysfunction.
• Loss of menstrual periods.
• Milk secretion from the breasts.
• Swelling of the body, arms, or legs, fever, weakness, fatigue (tiredness).
• Pain.
• A reaction at the injection site, including itching, pain, or swelling.
• Increased liver transaminases in the blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in the blood.
• Falls.

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Respiratory tract infection, bladder infection, ear infection, eye infection, tonsillitis, fungal infection of the nails, skin infection, localized infection in a single area of the skin or body, viral infection, skin inflammation caused by mites, abscess under the skin.

• Decreased number of white blood cells, decreased platelets (blood cells that help stop bleeding), decreased red blood cells.
• Allergic reaction.
• Sugar in the urine, diabetes, or worsening of diabetes.
• Loss of appetite that causes malnutrition and weight loss.
• Increased triglycerides in the blood (fat), increased cholesterol in the blood.
• Euphoria (mania), confusion, inability to reach orgasm, nervousness, nightmares.
• Loss of consciousness, seizures (epileptic fits), fainting.
• A restlessness that causes movement of body parts, balance disorder, abnormal coordination, dizziness when standing up, attention problems, speech problems, loss or alteration of taste, decreased sensitivity of the skin to pain or touch, sensation of tingling, pinching, or numbness of the skin.
• Eye infection or "red eye", dry eyes, increased tearing, eye redness.
• Sensation that everything is spinning (vertigo), ringing in the ears, ear pain.
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between the upper and lower parts of the heart, anomaly in the electrical activity of the heart, prolonged QT interval in the heart, slow heart rate, anomaly in the electrical conduction of the heart (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations).
• Decreased blood pressure when standing up (as a result, some people taking Risperdal Consta may feel weakness, dizziness, or loss of consciousness when getting up or sitting down suddenly).
• Rapid, shallow breathing, congestion of the airways, wheezing, nasal bleeding.
• Fecal incontinence, difficulty swallowing, excess gas or flatulence.
• Itching, hair loss, eczema, dry skin, skin redness, skin discoloration, acne, scaly or itchy skin or scalp.
• Increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released with muscle breakdown.
• Stiffness of the joints, swelling of the joints, muscle weakness, neck pain.
• Frequent urination, inability to urinate, painful urination.
• Ejaculation disorder, delayed menstruation, loss of menstrual periods or other problems with the cycle (women), development of breasts in men, sexual dysfunction, breast pain, breast tenderness, vaginal discharge.
• Swelling of the face, mouth, eyes, or lips.
• Chills, increased body temperature.
• Change in gait.
• Sensation of thirst, sensation of discomfort, chest discomfort, feeling "unwell".
• Hardening of the skin.
• Increased liver enzymes in the blood.

• Pain due to the procedure.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• Decreased number of a type of white blood cell that helps fight infections.
• Inadequate secretion of a hormone that controls urine volume.
• Low blood sugar.
• Excessive water intake.
• Sleepwalking.
• Sleep-related eating disorder.
• Lack of movement or response while awake (catatonia).
• Lack of emotions.
• Decreased level of consciousness.
• Head agitation.
• Eye movement problems, eye rotation, hypersensitivity of the eyes to light.
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken Risperdal Consta. If you need to undergo cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine.
• Irregular heartbeat.
• Dangerously low number of a type of white blood cell necessary to fight infections in the blood, increased eosinophils (a type of white blood cell) in the blood.
• Difficulty breathing during sleep (sleep apnea).
• Pneumonia caused by aspiration of food, lung congestion, crackling sounds in the lungs, voice disorder, respiratory tract disorder.
• Pancreatitis, intestinal obstruction.
• Very hard stools.
• Drug-related skin rash.
• Hives (or "urticaria"), skin thickening, dandruff, skin disorder, skin lesion.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).
• Posture abnormality.
• Increased breast size, milk secretion from the breasts.
• Decreased body temperature, discomfort.
• Yellowing of the skin and eyes (jaundice).
• Excessive water intake.
• Increased insulin (a hormone that controls blood sugar levels) in the blood.
• Brain blood vessel problems.
• No response to stimuli.
• Coma due to uncontrolled diabetes.
• Sudden loss of vision or blindness.
• Glaucoma (increased eye pressure), crusts on the eyelid margin.
• Flushing, tongue swelling.
• Cracked lips.
• Increased breast tissue.
• Decreased body temperature, coldness in the arms and legs.
• Drug withdrawal symptoms.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

• Complications of uncontrolled diabetes, which can be life-threatening.
• Severe allergic reaction with swelling, which can affect the throat and cause difficulty breathing.
• Lack of movement of the intestinal muscles that causes obstruction.

Frequency Not Known: cannot be estimated from the available data

• Severe or life-threatening skin rash with blisters and peeling of the skin that can start around the mouth, nose, eyes, genitals, and spread to other areas of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

The following adverse effect has occurred with the use of another medicine called paliperidone, which is very similar to risperidone, so it is also expected to occur with Risperdal Consta: Fast heart rate when standing up.

Reporting of Adverse Effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Risperdal Consta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C). If refrigeration is not available, the packaging can be stored below 25°C for a maximum of 7 days before administration. Administer within 6 hours after reconstitution (if stored at 25°C or below).

Store in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Risperdal Consta Composition

The active ingredient is risperidone.

Each Risperdal Consta powder and solvent for prolonged-release suspension for injection contains 50 milligrams of risperidone.

The other components are:

Powder

poly-(d,l-lactide-co-glycolide).

Solvent (solution):

Polysorbate 20, Sodium Carmellose, Disodium Hydrogen Phosphate Dihydrate, Anhydrous Citric Acid, Sodium Chloride, Sodium Hydroxide, Water for Injection.

Appearance of Risperdal Consta and Container Content

• A small vial containing the powder (in this powder is the active ingredient, risperidone). A preloaded syringe containing 2 ml of clear, colorless liquid to be added to the powder for prolonged-release suspension for injection.
• A vial adapter for reconstitution.
• Two Terumo SurGuard® 3 needles for intramuscular injection (one 21G UTW 1-inch (0.8 mm × 25 mm) safety needle with a protective needle safety device for deltoid administration and one 20G TW 2-inch (0.9 mm × 51 mm) safety needle with a protective needle safety device for gluteal administration).

Risperdal Consta is available in packs containing 1 to 5 grouped containers.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Janssen-Cilag, S.A.

Paseo del Club Deportivo 1, Edificio 16

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Janssen Pharmaceutica, N.V

Turnhoutseweg, 30

B-2340, Beerse

Belgium

This medicinal product has been authorized in the EEA Member States with the following names:

Austria: RISPERDAL CONSTA

Belgium: RISPERDAL CONSTA

Cyprus: RISPERDAL CONSTA

Czech Republic: RISPERDAL CONSTA

Denmark: RISPERDAL CONSTA

Estonia: RISPOLEPT CONSTA

Finland: RISPERDAL CONSTA

France: RISPERDAL CONSTA LP

Germany: RISPERDAL CONSTA 25mg, 37.5mg, 50mg

Greece: RISPERDAL CONSTA

Hungary: RISPERDAL CONSTA

Iceland: RISPERDAL CONSTA

Ireland: RISPERDAL CONSTA

Italy: RISPERDAL

Lithuania: RISPOLEPT CONSTA

Latvia: RISPOLEPT CONSTA

Liechtenstein: RISPERDAL CONSTA

Luxembourg: RISPERDAL CONSTA

Malta: RISPERDAL CONSTA

Netherlands: RISPERDAL CONSTA

Norway: RISPERDAL CONSTA

Poland: RISPOLEPT CONSTA

Portugal: RISPERDAL CONSTA

Romania: RISPOLEPT CONSTA

Slovakia: RISPERDAL CONSTA

Slovenia: RISPERDAL CONSTA

Spain: RISPERDAL CONSTA

Sweden: RISPERDAL CONSTA

United Kingdom: RISPERDAL CONSTA

This leaflet was last revised in:April 2021.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

IMPORTANT INFORMATION FOR THE HEALTHCARE PROFESSIONAL

Important Information

RISPERDAL CONSTA requires detailed attention to each step of the "Instructions for Use" to help ensure successful administration.

Use of Provided Components

The container components are specifically designed for use with RISPERDAL CONSTA. RISPERDAL CONSTA should only be reconstituted with the supplied solvent.

Do notsubstitute anyof the container components.

Do notstore the suspension after reconstitution.

Administer the dose as soon as possible after reconstitution to avoid sedimentation.

Appropriate Dose

The entire contents of the vial must be administered to ensure that the appropriate dose of RISPERDAL CONSTA is administered.

Do not reuse.Medical devices require materials with specific characteristics to function properly. These characteristics have been verified for single use. Any attempt to reprocess the device for subsequent reuse may negatively affect the integrity of the device or lead to deterioration of its function.

Container Components

Attach the Preloaded Syringe to the Vial Adapter